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Senior Director Global Regulatory Affairs
1 month ago
At Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Job SummaryWe are seeking a highly experienced Senior Director Global Regulatory Affairs to lead our Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The successful candidate will be responsible for developing and executing regulatory strategies for drug development and commercialization, ensuring compliance with global regulations and standards across multiple markets.
Key Responsibilities- Lead regulatory submissions, including pre-market applications, product registrations, post-approval updates, by ensuring accuracy, completeness, and timeliness.
- Monitor and interpret global regulatory requirements and trends, provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities.
- Remain knowledgeable of emerging regulatory developments, guidelines, and best practices in global markets, and proactively communicate updates and potential impacts to the organization.
- Oversee regulatory submission activities including the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc.
- Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial services.
- Support and liaise with regulatory officials and or clients during site inspections and audits.
- Provide regulatory expertise and guidance to internal teams, including commercial, R&D, quality, clinical, and marketing, throughout the drug product cycle.
- Responsible for the qualification and management of vendors and maintaining the approved supplier list.
- Lead and manage a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.
- Bachelor's degree in a relevant scientific discipline; at least 12+ years of relevant experience in a QRA position supporting drug product commercialization required, with a minimum of 3 years in a managing a team.
- Experience leading regulatory submissions and interactions with regulatory authorities in different countries with In-depth knowledge of global regulatory requirements, standards, and guidelines, with a focus on key markets.
- Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application.
- Strong leadership and management skills, with a track record of building and developing high-performing teams.
- Excellent analytical, problem-solving, and decision-making abilities; strong written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. This job is also eligible for bonus/incentive pay.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating an inclusive environment where all employees feel valued and respected.
